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510(k) K182654

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code NGG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2018
Date Received
September 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Methamphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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